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NCT Number: NCT06562712

Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management

This study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

Placenta accreta spectrum (PAS) is abnormal placental adhesion beyond superficial myometrium, which includes placenta accreta, placenta increta, and placenta percreta.

However, there is a desire to preserve the uterus and fertility, so alternatives to hysterectomy are needed. Presently, attempts to avoid hysterectomy include reducing intraoperative hemorrhage such as uterine compression sutures, intrauterine balloon tamponade, pelvic artery ligation, and spiral suturing of the lower uterine segment. Intrauterine balloon tamponade may increase CS scar dehiscence, uterine rupture, and infection. Combined with compression sutures, it may induce uterine necrosis.

Placement of balloons in the bilateral internal iliac arteries before caesarean section can reduce uterine artery pressure and intraoperative blood loss during balloon inflation, thus temporarily blocking the main blood supply of the uterus, helping to expose the visual field, shortening the operation time during surgery, and leading to opportunities for timely adjustments to the operative plan during surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 40 years.
  • Women with placenta accreta spectrum based on ultrasound (US) and/or magnetic resonance imaging (MRI) findings.

Exclusion criteria

  • Women with a bleeding disorder.
  • History of known allergy to contrast media.
  • Women with Impaired renal function.
  • Emergency cesarean section.
  • Women had severe attack of bleeding before the operation affecting patient's general condition.
  • Women had previous four or more cesarean scars.
  • If ultrasound (US) and magnetic resonance imaging (MRI) suspect the presence of placenta accrete preoperative, then intraoperative the placenta is found to have normal adhesion to the uterine wall, this case will be excluded.

Treatment and study plan

Conventional management

Procedure

Patients will be subjected to conventional management for placenta accreta spectrum.

Bilateral internal iliac artery balloon occlusion

Procedure

Patients will be subjected to bilateral internal iliac artery balloon occlusion for placenta accreta spectrum.

Primary outcomes

  1. Amount of intraoperative blood loss

    Time frame: Intraoperatively

    The amount of intraoperative blood loss will be calculated with reference to the contents of the suction apparatus and to weight of the surgical pads and the hemoglobin concentration difference, immediate preoperative (the morning of cesarean delivery) and postoperative (immediately after cesarean delivery) hemoglobin levels.

Secondary outcomes

  1. Operation time

    Time frame: From the start till the end of surgery

    Operation time will be recorded from start till end of surgery.

  2. Number of blood products units transfused

    Time frame: 24 hours postoperatively

    Number of blood products units transfused will be recorded.

  3. Hospitalization length

    Time frame: 28 days postoperatively

    Hospitalization length will be recorded from admission till discharge from hospital.

  4. Incidence of hysterectomy

    Time frame: 24 hours postoperatively

    Incidence of hysterectomy will be recorded.

  5. Intensive Care Unit (ICU) admission rate

    Time frame: 24 hours postoperatively

    Intensive Care Unit (ICU) admission rate will be recorded.

  6. Intraoperative complications

    Time frame: Intraoperatively

    Intraoperative complications such as bladder injury, ureteric ligature, and uterine atony will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Evaluation of Bilateral Internal Iliac Artery Balloon Occlusion in Placenta Accreta Spectrum Management: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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